Job Description - Clinical Operation Specialist
The prospective Clinical Operation Specialist will be a member of the Clinical Operations team which is responsible for the day to day planning, execution and management of clinical trials.
Responsibilities
- Provide support to the Clinical Operations Department
- Review regulatory documents for accurate content
- Contribute to the development of clinical documents
- Provide oversite of document version tracking and filing
- Perform investigator file reviews and logging of outstanding issues
- Attend meetings and teleconferences and generate and distribute agendas and minutes
- Oversee essential document management during all study phases
- Ensure clinical trials are conducted according to regulations and good clinical practices
- Assist in coordination and tracking of Investigator and third-party payments.
- Other study related tasks as required
Job Requirements
- Minimum of a bachelor’s degree in a scientific or health care discipline preferred
- Prior experience in pharmaceutical or biotech industry
- Minimum experience 4 years supporting clinical trials
- Highly effective team player with exceptional interpersonal skills building relationships with clinical trial sites
- Ability to work independently with little oversight and attention to detail and results oriented
- Ability to utilize critical thinking to analyze problems which may require multiple factors and approaches
- Sound judgement and problem solver – know when to escalate, report and make good decisions based on business objectives.
- Excellent oral and written communication skill
- This position requires some travel
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
Schedule:
Work setting:
Work Location: Remote